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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Continuous Measurement Thermometer
510(k) Number K202111
Device Name Medical infrared forehead thermometer
Applicant
Hunan Honggao Electronic Technolofy Co., Ltd.
Block 5, Tenghui Pioneer Park, Nanxian Economic Development
Yiyang,  CN 413200
Applicant Contact Rongfang Hu
Correspondent
Guangzhou Kinda Biological Technology Co., Ltd
6F, No.1 TianTai road, Science City, LuoGang District,
GuangZhou,  CN
Correspondent Contact Jet Li
Regulation Number880.2910
Classification Product Code
FLL  
Date Received07/30/2020
Decision Date 02/26/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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